GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Recent Major Announcements & Ongoing Reforms (Last 6 Months – July 2025 – January 2026)
1. National Conference on Strategic Trade Controls (NCSTC) 2026 ✓ HELD JAN 16-17, 2026
Status: Just completed (January 16-17, 2026, New Delhi)
Key Outcomes:
- SCOMET Framework Updates: Third edition of India’s Strategic Trade Control Handbook released, covering dual-use technologies, semiconductors, emerging technologies (quantum, AI, advanced computing)
- Participation: 500+ stakeholders including government, industry, academia, international partners
- Focus Areas:
- Licensing framework for dual-use goods
- Compliance mechanisms (Authorised Economic Operator program)
- Intangible Technology Transfer (ITT) controls
- Sector-specific sessions on chemicals, biotech, aerospace
- Emerging technologies (quantum, semiconductors, additive manufacturing, cybersecurity)
Relevance to SIDMA: Critical for understanding export compliance requirements for scientific instruments, medical devices with dual-use potential, and laboratory equipment with sensitive technology components.
Contact: DGFT (Directorate General of Foreign Trade)
2. Medical Device Sector Policy Updates (2025-2026)
a) Risk-Based Device Categorization (January 2026)
- 553 medical devices reclassified across cardiovascular and neurological segments
- Classification Matrix: Class D (highest risk, 221 devices) → Class A (lowest risk, 28 devices)
- Implementation: Risk-based surveillance intensity; high-risk devices face stricter scrutiny
- Impact: Affects licensing requirements, inspection frequency, and compliance obligations
b) Digital Regulatory Pathways (Implemented April 2025 onwards)
- Neutral Code System: Auto-generated codes for exports; no longer manual processing
- Subsequent Importer Pathway: Faster import approval for pre-approved devices
- Market Standing Certificates (MSC) & Non-Conviction Certificates (NCC): Fully digitalized through online portal
- Impact: Simplified export documentation; reduced processing time; increased transparency
c) Labelling Norm Amendments (September 2025)
- Medical Device Rules 2017 Override: MDR 2017 now sole labelling requirement (removes LMPC overlap)
- Benefit: Single, uniform labelling standard; eliminated conflicting requirements
- Effective From: September 2025
3. Medical Device Software Regulation (Draft Guidance – 2025)
Status: Draft guidance issued by CDSCO; implementation timeline TBD (expected 2026)
Key Provisions:
- Risk Classification: 4-tier system for Software as Medical Device (SaMD):
- Class A: Low risk (minimal patient harm potential)
- Class B: Low-to-moderate risk
- Class C: Moderate-to-high risk
- Class D: High risk (critical to life functions)
- Quality Management System: Mandatory IS/ISO 13485 compliance
- Algorithm Change Protocol: AI/ML algorithm updates require documentation, validation, regulatory notification
- Post-Market Surveillance: Cybersecurity vulnerability reporting, adverse event monitoring
Relevance: Applies to diagnostic software, monitoring systems, AI-powered devices
4. Medical Device Regulatory Amendments (Proposed – Expected 2026)
Draft proposals include:
- Perpetual Validity Licenses: Manufacturing and import licenses now perpetual (subject to annual retention fees instead of periodic renewal)
- Class A Registration Pathway: Simplified registration for low-risk, non-sterile, non-measuring devices
- Inspection Rationalization: Risk-based inspection scheduling; sampling optimization
- IVD Testing Laboratory Requirements: Enhanced reporting obligations; standardized quality schedules
Benefit: Reduced regulatory friction; greater certainty on license validity; streamlined compliance
A. Market Opportunities (2026 Focus)
| Opportunity | Timeline | Key Players | SIDMA Relevance |
| PLI Scheme Expansion | Ongoing | Siemens, Philips, BPL, Panacea | High—manufacturing support for complex devices |
| RDI Fund Access | May 2026 onwards | Startups, MSMEs, established firms | High—₹1 lakh crore innovation financing |
| Medical Device Parks | March 2027 | UP (Noida), TN, MP, HP | High—manufacturing infrastructure & common facilities |
| Export Gateway (WHX Dubai) | Feb 9-12, 2026 | Exporters, international traders | Critical—Middle East & Africa market access |
| Export Gateway (Korea Pharma) | Mar 31-Apr 3, 2026 | Pharma machinery, lab equipment exporters | High—Northeast Asia & South Korea market entry |
B. Risk & Compliance Factors
| Risk Factor | Mitigation |
| SCOMET Dual-Use Controls | Early awareness of NCSTC 2026 updates; ensure compliance documentation for exports |
| Software Device Regulation (Pending) | Monitor CDSCO draft guidance; begin AI/ML documentation frameworks now if applicable |
| Customs Duty Uncertainty | Budget 2026-27 decision pending; prepare pricing strategies for both scenarios (7.5% vs. 10-15%) |
| License/Certification Updates | Track BIS compulsory certification list; plan for testing facility access early |
| Medical Device Park Infrastructure | Noida park delayed to March 2027; early plot allotment recommended if manufacturing expansion planned |